Pilot Trial for Implementation of a MPA PK Monitoring Strategy

• Status: Completed
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is a prospective interventional trial of de novo renal transplant recipients, aiming to validate a strategy which combines the use of early post transplant MPA AUC sampling, and subsequent MPA trough level monitoring to implement MPA PK monitoring in a clinically applicable fashion.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Collaborator: Hoffmann-La Roche
• Treatments: Cyclosporine; Cyclosporins; Mycophenolate mofetil; Mycophenolic Acid; Tacrolimus

Criteria

Inclusion Criteria:

• primary or secondary cadaveric or living donor kidney recipients

• On Cellcept

Exclusion Criteria:

• Multi organ recipients

• Documented non-compliance

• Not on a calcineurin inhibitor

• GFR <25 ml/min by Cockcroft Gault equation

• Serum albumin <2.5 mg/dl

• Pregnant

• Active serious digestive disorder